BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2202295 · Received August 11, 2011

    Report

    Report Number
    9616099-2011-00614
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 16, 2009
    Report Date
    July 14, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT POST VENA CAVA OPTEASE FILTER IMPLANTATION THE FILTER WAS TILTED IN THE TARGET VESSEL. THERE ARE NO PATIENT DEMOGRAPHICS AVAILABLE TO DATE. A LITERATURE SEARCH REVEALED THE FOLLOWING JOURNAL ARTICLE: ONAT ET AL. "OPTEASE AND TRAPEASE VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE IN 258 CASES" CARDIOVASC INTERVENT RADIOL (2009) 32:992-997 DOI 10.1007/S00270-009-9591. ABSTRACT: WE AIMED TO EVALUATE THE EFFICACY AND SAFETY OF THE OPTEASE AND TRAPEASE (BOTH FROM CORDIS, (B)(4)) VENA CAVA FILTERS IN THE PREVENTION OF PULMONARY EMBOLISM (PE). BETWEEN MAY 2004 AND DECEMBER 2008, OPTEASE (PERMANENT/RETRIEVABLE; N = 228) OR TRAPEASE (PERMANENT; N = 30) VENA CAVA FILTERS WERE PLACED IN 258 PATIENTS (160 FEMALE AND 98 MALE; MEAN AGE 62 YEARS [RANGE 22 TO 97]). INDICATIONS WERE AS FOLLOWS: PROPHYLAXIS FOR PE (N = 239), CONTRAINDICATION FOR ANTICOAGULATION IN THE PRESENCE OF PE OR DVT (N = 10), AND DEVELOPMENT OF PE OR DVT DESPITE ANTICOAGULATION (N = 9). MEDICAL RECORDS WERE RETROSPECTIVELY REVIEWED FOR INDICATIONS, CLINICAL RESULTS, AND PROCEDURE-RELATED COMPLICATIONS DURING PLACEMENT AND RETRIEVAL. CLINICAL PE DID NOT DEVELOP IN ANY OF THE PATIENTS. HOWEVER, RADIOLOGIC SIGNS OF SEGMENTAL PE WERE SEEN IN 6 OF 66 PATIENTS WITH FOLLOW-UP IMAGING DATA. MIGRATION OR FRACTURE OF THE FILTER OR CAVA PERFORATION WAS NOT SEEN IN ANY OF THE PATIENTS. EXCEPT FOR A SINGLE CASE OF ASYMPTOMATIC TOTAL CAVA THROMBOSIS, NO THROMBOTIC OCCLUSION WAS OBSERVED. ONE HUNDRED FORTY-ONE PATIENTS WERE SCHEDULED TO UNDERGO FILTER REMOVAL; HOWEVER, 17 OF THEM WERE NOT SUITABLE FOR SUCH BASED ON VENOGRAPHY EVALUATION. REMOVAL WAS ATTEMPTED IN 124 PATIENTS AND WAS SUCCESSFUL IN 115 OF THESE (MEAN DURATION OF RETENTION 11 DAYS [RANGE 4 TO 23]). NINE FILTERS COULD NOT BE REMOVED. PERMANENT/RETRIEVABLE VENA CAVA FILTERS ARE SAFE AND EFFECTIVE DEVICES FOR PE PROPHYLAXIS AND FOR THE MANAGEMENT OF VENOUS THROMBOEMBOLISM BY PROVIDING THE OPTION TO BE LEFT IN PLACE. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. FILTER TILT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IVC FILTER IMPLANTATION AND IN LISTED IN THE OPTEASE IFU AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, TARGET VESSEL AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT OF FILTER TILT.

    Additional Manufacturer Narrative · 1

    ABSTRACT: WE AIMED TO EVALUATE THE EFFICACY AND SAFETY OF THE OPTEASE AND TRAPEASE (BOTH FROM CORDIS, (B)(4)) VENA CAVA FILTERS IN THE PREVENTION OF PULMONARY EMBOLISM (PE). BETWEEN (B)(6) 2004 AND (B)(6) 2008, OPTEASE (PERMANENT/RETRIEVABLE; N = 228) OR TRAPEASE (PERMANENT; N = 30) VENA CAVA FILTERS WERE PLACED IN 258 PATIENTS (160 FEMALE AND 98 MALE; MEAN AGE 62 YEARS [RANGE 22 TO 97]). INDICATIONS WERE AS FOLLOWS: PROPHYLAXIS FOR PE (N = 239), CONTRAINDICATION FOR ANTICOAGULATION IN THE PRESENCE OF PE OR DVT (N = 10), AND DEVELOPMENT OF PE OR DVT DESPITE ANTICOAGULATION (N = 9). MEDICAL RECORDS WERE RETROSPECTIVELY REVIEWED FOR INDICATIONS, CLINICAL RESULTS, AND PROCEDURE-RELATED COMPLICATIONS DURING PLACEMENT AND RETRIEVAL. CLINICAL PE DID NOT DEVELOP IN ANY OF THE PATIENTS. HOWEVER, RADIOLOGIC SIGNS OF SEGMENTAL PE WERE SEEN IN 6 OF 66 PATIENTS WITH FOLLOW-UP IMAGING DATA. MIGRATION OR FRACTURE OF THE FILTER OR CAVA PERFORATION WAS NOT SEEN IN ANY OF THE PATIENTS. EXCEPT FOR A SINGLE CASE OF ASYMPTOMATIC TOTAL CAVA THROMBOSIS, NO THROMBOTIC OCCLUSION WAS OBSERVED. ONE HUNDRED FORTY-ONE PATIENTS WERE SCHEDULED TO UNDERGO FILTER REMOVAL; HOWEVER, 17 OF THEM WERE NOT SUITABLE FOR SUCH BASED ON VENOGRAPHY EVALUATION. REMOVAL WAS ATTEMPTED IN 124 PATIENTS AND WAS SUCCESSFUL IN 115 OF THESE (MEAN DURATION OF RETENTION 11 DAYS [RANGE 4 TO 23]). NINE FILTERS COULD NOT BE REMOVED. PERMANENT/RETRIEVABLE VENA CAVA FILTERS ARE SAFE AND EFFECTIVE DEVICES FOR PE PROPHYLAXIS AND FOR THE MANAGEMENT OF VENOUS THROMBOEMBOLISM BY PROVIDING THE OPTION TO BE LEFT IN PLACE. CONCLUSION: OPTEASE AND TRAPEASE VENA CAVA FILTERS ARE SAFE AND EFFECTIVE DEVICES FOR PE PROPHYLAXIS AND FOR THE MANAGEMENT OF VTE. THE MOST IMPORTANT LIMITATION OF OPTEASE AS A RETRIEVABLE FILTER IS ITS REQUIREMENT FOR AN EARLY RETRIEVAL. AS SUCCESSFUL RETRIEVAL RATES INCREASE, THE USE OF VENA CAVA FILTERS WILL BECOME MORE COMMON. IT SEEMS POSSIBLE THAT RETRIEVABLE FILTERS MAY ALSO BE USED AS PERMANENT FILTERS WHEN NECESSARY AND THAT THE USE OF PERMANENT FILTERS EVENTUALLY MAY BE COMPLETELY ABANDONED. HOWEVER, FURTHER LONG-TERM AND LARGE-SCALE PROSPECTIVE STUDIES ARE WARRANTED BEFORE A DEFINITE CONCLUSION CAN BE ACHIEVED. OPTEASE AND TRAPEASE VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE IN 258 PATIENTS-JOURNAL ARTICLE. WE HAVE CAPTURED THE PRODUCT ISSUES IN THIS ARTICLE AS: FILTER/TILT (9): (B)(4). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A LITERATURE SEARCH REVEALED THE FOLLOWING JOURNAL ARTICLE: ONAT ET AL. "OPTEASE AND TRAPEASE VENA CAVA FILTERS: A SINGLE-CENTER EXPERIENCE IN 258 CASES" CARDIOVASC INTERVENT RADIOL (2009) 32:992-997 DOI 10.1007/S00270-009-9591. THE ARTICLE/REPORT STATED THAT IN ONE (1) PATIENT THE FILTER HOOK WAS IN CLOSE PROXIMITY TO THE CAVA WALL, AND THE FILTER WAS TILTED BUT THE FILTER HOOK COULD NOT BE GRASPED BY THE SNARE. THUS, THE FILTER COULD NOT BE REMOVED. A TOTAL OF NINE (9) PATIENTS WERE CAPTURED FROM THE ARTICLE WITH THE PRODUCT ISSUE OF FILTER/TILT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1